JP2018153452A - Balloon catheter and method of treating lesion of living body lumen using balloon catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a balloon catheter which, when an inflation pressure of the balloon is adapted to a lesion, can appropriately prevent an axial displacement of the balloon, and also to provide a treatment method using the balloon catheter.SOLUTION: The balloon catheter includes an inner tube shaft 40, a first outer tube shaft arranged around an outer peripheral surface side of the inner tube shaft, and a second outer tube shaft arranged around an outer peripheral surface side of the first outer tube shaft. The second outer tube shaft forms a second flow channel in which a fluid is movable between the first and second outer tube shafts. The balloon catheter also includes an inner balloon 70 and an outer balloon 80 covering the inner balloon. The outer balloon forms a protruded part 100 protruding to a side of an outer surface 80S of the outer balloon when inflated by injection of the fluid into the second flow channel. The protruded part produces a negative pressure between the outer balloon and a wall of a living body lumen by exhaustion of the fluid from the second flow channel when the protruded part is in contact with the wall of the living body lumen.SELECTED DRAWING: Figure 3

Description

  The present invention relates to a balloon catheter and a method for treating a lesion site of a biological lumen using the balloon catheter.

  2. Description of the Related Art Balloon catheters (medical long bodies) are known as medical instruments used to expand a lesion site (stenosis, etc.) formed in a body lumen such as a blood vessel or to place a stent or the like in a lesion site. . The balloon catheter includes a balloon fixed to the distal end side of the shaft.

  The balloon catheter is introduced into the living body lumen from the puncture site via an introducer sheath, a guiding catheter, or the like, and delivered to the lesion site. In order to improve the operability in the living body lumen when moving the living body lumen, the balloon catheter preferably has a smaller frictional resistance between the outer surface of the balloon and the living body lumen wall. On the other hand, when the balloon catheter is expanded at a lesion site in the living body lumen, it is preferable that the frictional resistance between the outer surface of the balloon and the living body lumen wall is large in order to suppress positional displacement in the axial direction of the balloon. .

  For example, in order to suppress the positional displacement of the balloon with respect to the lesion site while improving the operability in the living body lumen, a balloon catheter in which the friction coefficient of a part of the outer surface of the balloon is improved is known (for example, , See Patent Document 1). The balloon catheter is configured such that when the balloon is deflated, the portion with improved friction coefficient is not exposed to the outside, and when the balloon is expanded, the portion with improved friction coefficient is exposed to the outside. Yes.

JP 2005-224635 A

  However, the outer surface of the balloon is not fixed to the living body lumen wall due to a physical structure or action when the balloon is expanded. Therefore, even if the balloon catheter improves the frictional resistance of the outer surface of the balloon, as the outer diameter of the balloon increases during expansion, the balloon catheter slips between the outer surface of the balloon and the body lumen wall. A positional shift in the axial direction may occur. In the balloon catheter, when an operator such as a doctor expands the balloon, moisture such as blood exists between the outer surface of the balloon and the living body lumen wall. Therefore, the balloon catheter is formed between the outer surface of the balloon and the living body lumen wall by moisture existing between the living body lumen wall and the outer surface of the balloon before the outer surface of the balloon contacts the living body lumen wall. There is a possibility that slippage may occur between the balloons and the balloon may be displaced in the axial direction.

  The present invention has been made in view of the above-described problem, and when adapting balloon expansion pressure to a lesion site, a balloon catheter and a lesion site of a biological lumen that can suitably prevent displacement of the balloon in the axial direction. The object is to provide a method for the treatment.

  In order to achieve the above object, the balloon catheter of the present invention includes an inner tube shaft through which a guide wire can be inserted, a first outer tube shaft disposed on the outer peripheral surface side of the inner tube shaft, and the first outer tube shaft. And a second outer tube shaft disposed on the outer peripheral surface side. The first outer tube shaft forms a first space in which fluid can move with the inner tube shaft. The second outer tube shaft forms a second space in which a fluid can move with the first outer tube shaft. The balloon catheter according to the present invention includes an inner balloon fixed to a distal end side of the inner tube shaft and a distal end side of the first outer tube shaft, a distal end side of the inner tube shaft, and a distal end side of the second outer tube shaft. And an outer balloon fixed and covering the inner balloon. The outer balloon forms a convex portion that protrudes to the outer surface side of the outer balloon in a state where the outer balloon is expanded by injecting fluid into the second space. The convex portion generates a negative pressure between the outer balloon and the biological lumen wall by discharging the fluid in the second space in a state where the convex portion is in contact with the biological lumen wall. .

  In order to achieve the above object, a method for treating a lesion site in a living body lumen includes an inner tube shaft into which a guide wire can be inserted, an outer tube surface disposed on the outer tube surface, and the inner tube shaft. Between the first outer tube shaft and a first outer tube shaft that forms a first space in which the fluid can move, and between the first outer tube shaft and the first outer tube shaft. A second outer tube shaft that forms a movable second space; a tip side of the inner tube shaft; an inner balloon fixed to the tip side of the first outer tube shaft; a tip side of the inner tube shaft; A balloon catheter having an outer balloon that is fixed to the distal end side of the second outer tube shaft and covers the inner balloon is inserted into the living body lumen, and the outer balloon is placed at the lesion site of the living body lumen. And the convex part which protrudes to the outer surface side of the said outer balloon, expanding the said outer balloon in the circumferential direction by inject | pouring a fluid into the said 2nd space in the state which has arrange | positioned the said outer balloon in the said lesion site | part Form. Further, in an expanded state of the outer balloon, the inner balloon is expanded in the circumferential direction so that the convex portion of the outer balloon is in contact with the lesion site, the convex portion is in contact with the lesion site, and the In a state where the inner balloon is expanded, the outer balloon is deflated to generate a negative pressure between the convex portion and the lesion site, and the outer balloon is adsorbed to the lesion site. Then, the inner balloon is further expanded in the circumferential direction in a state where the inner balloon is expanded and the outer balloon is adsorbed to the lesion site, whereby the inner balloon is passed through the outer balloon to the lesion site. Adapt the expansion power of.

  According to the balloon catheter and the method for treating a lesion site in a living body lumen according to the present invention, the balloon catheter projects to the outer surface side of the outer balloon in a state of being expanded by injecting fluid into the second space. Protrusions are formed. And a convex part produces | generates a negative pressure between an outer balloon and a biological lumen wall by the fluid of 2nd space being discharged | emitted in the state which the said convex part contacted the biological lumen wall. Thereby, the surgeon can adsorb the convex part of the outer balloon to the living body lumen wall before expanding the inner balloon and applying the expansion force by the inner balloon to the lesion site via the outer balloon. Therefore, the operator can reduce the change in the positional relationship between the balloon and the lesioned part by adsorbing the convex part to the living body lumen wall when the expansion force by the inner balloon is applied to the lesioned part via the outer balloon. Therefore, according to the balloon catheter and the method for treating a lesion site of a living body lumen according to the present invention, when the expansion pressure of the balloon is applied to the lesion site, it is possible to prevent the displacement of the balloon in the axial direction.

1A is a view showing a balloon catheter according to an embodiment of the present invention, and FIG. 1B is an enlarged view of a portion indicated by a broken line portion 1B in FIG. 1A. C) is an enlarged cross-sectional view of a portion indicated by a broken line portion 1C in FIG. 2A is a cross-sectional view taken along line 2A-2A in FIG. 1B, and FIG. 2B is a cross-sectional view taken along line 2B-2B in FIG. 3A is a cross-sectional view taken along line 3A-3A in FIG. 1B, and FIG. 3B is an enlarged cross-sectional view of a portion indicated by a broken line portion 3B in FIG. 3A. It is a figure which shows a mode that the balloon of the balloon catheter which concerns on embodiment of this invention is arrange | positioned in a constriction part. FIG. 5 (A) is a cross-sectional view showing a state in which the balloon of the balloon catheter according to the embodiment of the present invention is disposed in the stenosis, and FIG. 5 (B) is convex on the outer surface of the outer balloon of the balloon catheter. FIG. 5C is a cross-sectional view showing a state in which the inner balloon is expanded in a state in which a convex portion is formed on the outer surface of the outer balloon of the balloon catheter. FIG. 5D is a cross-sectional view showing a state in which a negative pressure is generated between the outer balloon of the balloon catheter and the living body lumen wall. FIG. 6 is an enlarged cross-sectional view of a portion indicated by a broken line portion 6 in FIG. It is an expanded sectional view corresponding to Drawing 3 (A) showing a balloon catheter concerning a modification. It is an expanded sectional view corresponding to Drawing 3 (A) showing a balloon catheter concerning another modification.

  Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

  1-3 is a figure which shows the structure of each part of the balloon catheter 1 which concerns on embodiment.

  In the balloon catheter 1 according to the present embodiment, the shaft 10 is inserted into the living body lumen V, and the balloon 20 disposed on the distal end side of the shaft 10 is expanded at the lesion site N (stenosis portion or the like), thereby causing the lesion site N. It is configured as a medical device that spreads and treats. The lesion site N is a place where the living body lumen V surrounded by the living body lumen wall Vw is narrow.

  The balloon catheter 1 can be configured, for example, as a PTCA dilatation balloon catheter used to expand a stenosis of a coronary artery. However, the balloon catheter 1 is intended for the treatment and improvement of stenosis formed in living organs such as other blood vessels, bile ducts, trachea, esophagus, other digestive tracts, urethra, ear nasal lumen, and other organs. It can also be configured as used.

  With reference to FIGS. 1-3, the structure of each part of the balloon catheter 1 is demonstrated.

  1A, 1B, and 1C, a balloon catheter 1 includes a long shaft 10, a balloon 20 disposed on the distal end side of the shaft 10, and a proximal end side of the shaft 10. And a hub 30 disposed on the surface.

  In this specification, the side of the balloon catheter 1 that is inserted into the living body lumen V (the side on which the balloon is disposed) is referred to as the distal end side, and the side that is operated on the side opposite to the distal end side (the hub is connected). The side on which the balloon is disposed is referred to as the proximal end side, and the direction in which the balloon extends is referred to as the axial direction of the balloon. Further, in the description of the embodiments, the distal end portion means a certain range including the distal end (the most distal end) and the periphery thereof, and the proximal end portion means a certain range including the proximal end (the most proximal end) and the periphery thereof. Means range.

  2 (A) and 2 (B), shaft 10 has a guide wire lumen L through which guide wire W can be inserted. The balloon catheter 1 is configured as a so-called over-the-wire type balloon catheter in which a guide wire lumen L extends from the distal end of the shaft 10 to the proximal end.

  The shaft 10 includes an inner tube shaft 40 through which a guide wire W can be inserted, a first outer tube shaft 50 disposed on the outer surface 40S side of the inner tube shaft 40, and an outer surface of the first outer tube shaft 50. And a second outer tube shaft 60 disposed on the 50S side.

  The inner tube shaft 40 has a lumen 41 that forms a guide wire lumen L. The lumen 41 of the inner tube shaft 40 communicates with a passage 31 of the hub 30 described later in a state where the proximal end side of the inner tube shaft 40 is connected to the hub 30 (see FIG. 1C).

  The first outer pipe shaft 50 forms a first flow path 51 (corresponding to a first space) in which fluid can move between the first outer pipe shaft 50 and the inner pipe shaft 40. The second outer tube shaft 60 forms a second flow path 61 (corresponding to the second space) in which fluid can move between the first outer tube shaft 50.

  The first flow path 51 communicates with a first lumen 71 of an inner balloon 70 described later on the distal end side of the first outer tube shaft 50. The second flow path 61 communicates with a second lumen 81 of the outer balloon 80 described later on the distal end side of the second outer tube shaft 60.

  The first flow path 51 communicates with a lumen 35a of a first port 35 of the hub 30 described later on the proximal end side of the first outer tube shaft 50 (see FIG. 1C). The second flow path 61 communicates with a lumen 36a of a second port 36 of the hub 30 described later on the proximal end side of the second outer tube shaft 60 (see FIG. 1C).

  The balloon 20 includes an inner balloon 70 and an outer balloon 80 that covers the inner balloon 70. The inner balloon 70 is fixed to the distal end side of the inner tube shaft 40 and the distal end side of the first outer tube shaft 50. The outer balloon 80 is fixed to the distal end side of the inner tube shaft 40 and the distal end side of the second outer tube shaft 60. The outer balloon 80 is fixed to the distal end side of the inner tube shaft 40 via the inner balloon 70.

  The inner balloon 70 has a first lumen 71 (corresponding to a first space) communicating with the first flow channel 51 in a state where it is connected to the shaft 10. The inner balloon 70 expands when fluid (for example, contrast medium or physiological saline) injected into the first flow path 51 flows into the first lumen 71. In addition, the inner balloon 70 contracts when fluid is discharged from the first lumen 71 via the first flow path 51 in the expanded state.

  The outer balloon 80 has a second lumen 81 (corresponding to a second space) communicating with the second flow path 61 in a state where it is connected to the shaft 10. The outer balloon 80 expands when fluid (for example, contrast medium or physiological saline) injected into the second flow path 61 flows into the second lumen 81. In addition, the outer balloon 80 contracts when fluid is discharged from the second lumen 81 through the second flow path 61 in the expanded state.

  The outer balloon 80 includes a first intermediate region 85 having a distal end and a proximal end, a first distal side inclined portion 86 inclined from the distal end of the first intermediate region 85 toward the inner tube shaft 40, and the first intermediate region 85. And a first base end side inclined portion 87 that inclines toward the second outer tube shaft 60 from the base end.

  The inner balloon 70 includes a second intermediate region 75 having a distal end and a proximal end, a second distal side inclined portion 76 that is inclined from the distal end of the second intermediate region 75 toward the inner tube shaft 40, and the second intermediate region 75. And a second base end side inclined portion 77 that inclines toward the second outer tube shaft 60 from the base end.

  The inner tube shaft 40 has a tip 45 on the tip side. The tip tip 45 has a tapered shape with an outer diameter that decreases toward the tip side. A through hole 46 that penetrates the tip tip 45 in the axial direction is formed inside the tip tip 45. Therefore, the through hole 46 forms a part of the guide wire lumen L.

  The distal tip 45 can be formed of a flexible resin member having heat shrinkability, for example. However, the material of the tip 45 is not particularly limited as long as it can be fixed to the inner tube shaft 40.

  The inner tube shaft 40 is provided with a distal tip 45 on the distal end side, thereby suitably preventing the living organ from being damaged when the tip of the balloon catheter 1 comes into contact with the living organ (such as the inner wall of the blood vessel). be able to.

  An X-ray contrast marker C indicating the position of the balloon 20 is provided on the inner tube shaft 40. The X-ray contrast marker C is disposed at a position indicating a boundary portion between the first distal side inclined portion 86 and the first intermediate region 85 and a boundary portion between the first intermediate region 85 and the first proximal end inclined portion 87. .

  The X-ray contrast marker C includes a distal end side marker C1 disposed at a position corresponding to the first distal end side inclined portion 86 on the inner tube shaft 40, and a position corresponding to the first proximal end inclined portion 87 on the inner tube shaft 40. And a proximal-side marker C2. The end surface on the proximal end side of the distal end side marker C <b> 1 is disposed at a boundary portion between the first distal end side inclined portion 86 and the first intermediate region 85. Further, the end face on the distal end side of the proximal end side marker C <b> 2 is disposed at a boundary portion between the first intermediate region 85 and the first proximal end inclined portion 87.

  The X-ray contrast marker C can be composed of, for example, a metal such as platinum, gold, silver, iridium, titanium, tungsten, or an alloy thereof.

  Referring to FIG. 1C, the hub 30 has a passage 31 that communicates with the lumen 41 of the inner tube shaft 40 in a state where the proximal end side of the inner tube shaft 40 is connected to the hub 30. The guide wire W is inserted into the lumen 41 of the inner tube shaft 40 via the passage 31 in a state where the inner tube shaft 40 and the hub 30 are connected.

  The hub 30 has a first port 35 and a second port 36. The first port 35 has a lumen 35 a that communicates with the first flow path 51 in a state where the proximal end side of the shaft 10 is connected to the hub 30. The second port 36 has a lumen 36 a that communicates with the second flow path 61 in a state where the proximal end side of the shaft 10 is connected to the hub 30. The fluid is injected into and discharged from the first flow path 51 through the first port 35. In addition, the fluid is injected into and discharged from the second flow path 61 through the second port 36.

The first port 35 is configured to be connectable in a liquid-tight and air-tight manner with a supply device (not shown) such as an indeflator for supplying and discharging a fluid (pressurized medium) to and from the first flow path 51. . Similarly, the second port 36 is configured to be connectable to a supply device (not shown) such as an indeflator for supplying and discharging a fluid (pressurized medium) to the second flow path 61 in a liquid-tight and air-tight manner. The first port 35 and the second port 36 may be configured by, for example, a known luer taper configured such that a tube for supplying and discharging fluid is connectable and separable.

  The inner balloon 70 and the outer balloon 80 will be described in detail.

  Referring to FIGS. 2A and 2B, the outer balloon 80 has a convex portion 100 protruding toward the outer surface 80S of the outer balloon 80 in a state where the outer balloon 80 is expanded by injecting fluid into the second flow path 61. Form. The convex part 100 generates a negative pressure between the outer balloon 80 and the living body lumen wall Vw by discharging the fluid in the second flow path 61 in a state of being formed on the outer surface 80S of the outer balloon 80. (See FIG. 5D and FIG. 6).

  The convex portion 100 protrudes in the radial direction of the outer balloon 80 from the outer surface 80S of the outer balloon 80 in a state where the outer balloon 80 is expanded by injecting fluid into the second flow path 61. The protrusion amount of the convex portion 100 can be appropriately set according to the shape of the lesion site N to be treated with the balloon catheter 1. The convex portion 100 has a substantially rectangular shape in plan view (see FIG. 1B).

  The convex portion 100 is formed in the first intermediate region 85 of the outer balloon 80. The convex portion 100 has a first convex portion 101 and a second convex portion 102 that are arranged at different locations in the axial direction of the outer balloon 80 in the first intermediate region 85. The 1st convex part 101 is arrange | positioned at the front-end | tip part 85a of the 1st intermediate | middle area | region 85 (refer FIG. 1 (B)). The 2nd convex part 102 is arrange | positioned at the base end part 85b of the 1st intermediate | middle area | region 85 (refer FIG. 1 (B)).

  The second intermediate region 75 of the inner balloon 70 is disposed at a corresponding position between the first convex portion 101 and the second convex portion 102 in a state where the inner balloon 70 and the outer balloon 80 are expanded. Specifically, the second intermediate region 75 extends between the distal end of the first convex portion 101 and the proximal end of the second convex portion 102 in the axial direction of the inner balloon 70.

  With reference to FIG. 3A, the convex portion 100 has an upper region 110 and a bottom region 120 formed on the inner balloon 70 side than the upper region 110. The convex portion 100 discharges the fluid in the second flow path 61 in a state where the outer balloon 80 is expanded by injecting fluid into the second flow path 61 and the convex section 100 is in contact with the living body lumen wall Vw. As a result, a decompression space Sr is formed between the upper region 110 and the biological lumen wall Vw (see FIG. 6).

  The upper region 110 is disposed on the radial direction side of the convex portion 100 and forms an end portion of the convex portion 100 on the radial direction side. The bottom region 120 extends from the edge of the top region 110 to the outer surface 80S of the outer balloon 80.

  The upper region 110 extends along a plane substantially orthogonal to the radial direction of the outer balloon 80. The bottom region 120 extends in a direction substantially orthogonal to the direction in which the upper region 110 extends.

  The convex portion 100 has an internal space 130 into which the fluid in the second flow path 61 flows in a state where the outer balloon 80 is expanded. The internal space 130 is surrounded by the upper region 110 and the bottom region 120.

  The outer balloon 80 has a communication path 140 between the inner space 130 and the second lumen 81. The communication path 140 is disposed so as to connect the internal space 130 and the second lumen 81 along the radial direction of the outer balloon 80. The communication path 140 extends along the axial direction of the balloon 20 in a region where the convex portion 100 is disposed in a plan view of the outer balloon 80 (see FIG. 1B).

  When the outer balloon 80 is expanded, the fluid injected into the second flow path 61 flows into the internal space 130 via the second lumen 81 and the communication path 140. Thereby, the convex part 100 which protrudes to the outer surface 80S side of the balloon 20 is formed. Further, when the outer balloon 80 is deflated, the fluid that has flowed into the internal space 130 is discharged to the second flow path 61 via the communication path 140 and the second lumen 81. Thereby, the convex part 100 formed in the outer surface 80S of the balloon 20 contracts.

  The upper region 110 faces the living body lumen wall Vw when the convex portion 100 protruding to the outer surface 80S side of the outer balloon 80 is formed (see FIG. 6). The upper region 110 is directed toward the second lumen 81 side of the outer balloon 80 by discharging the fluid in the second flow path 61 in a state where the convex portion 100 is formed on the outer surface 80S side of the outer balloon 80. Recessed (see FIG. 5D and FIG. 6).

  A plurality of first convex portions 101 are arranged in the circumferential direction of the outer balloon 80. Three first convex portions 101 are arranged at equal intervals in the circumferential direction of the outer balloon 80 (indicated by reference numerals 101A, 101B, and 101C in FIGS. 1B and 3A).

  A plurality of second convex portions 102 are arranged in the circumferential direction of the outer balloon 80. Three second convex portions 102 are arranged at equal intervals in the circumferential direction of the outer balloon 80 (indicated by reference numerals 102A, 102B, and 102C in FIG. 1B).

  With reference to FIG. 3 (B), when the convex part 100 is formed in the outer surface 80S side of the outer side balloon 80, the part facing the biological lumen wall Vw becomes thin. Specifically, in the convex portion 100, the thickness T1 of the upper region 110 is thinner than the thickness T2 of the bottom region 120. The thickness T1 of the upper region 110 and the thickness T2 of the bottom region 120 are not particularly limited as long as the thickness T1 of the upper region 110 is smaller than the thickness T2 of the bottom region 120. For example, the thickness of the upper region 110 T1 can be about 0.015 mm, and the thickness T2 of the bottom region 120 can be about 0.03 mm. The upper region 110 preferably has a thickness T1 that is smaller than the thickness T2 of the bottom region 120 and extends along a plane that is substantially perpendicular to the radial direction of the outer balloon 80. Accordingly, when the outer balloon 80 is deflated, the edge of the portion of the upper region 110 facing the internal space 130 of the upper region 110 is deformed due to the difference in rigidity between the upper region 110 and the bottom region 120. Since it is easy, it can be dented more smoothly toward the internal space 130.

  The length H1 of the upper region 110 (equal to the thickness T1 in the embodiment of FIG. 3) is shorter than the length H2 of the bottom region 120 in a cross section perpendicular to the axial direction of the inner tube shaft 40. The length H2 of the bottom region 120 is not particularly limited as long as it is longer than the length (wall thickness T1) of the upper region 110, but may be, for example, about 0.06 mm. The length of the upper region is perpendicular to the axial direction of the inner tube shaft 40 from the portion of the upper region 110 located closest to the radial direction to the bottom region 120 in a cross section perpendicular to the axial direction of the inner tube shaft 40. Say distance.

  The width D1 of the internal space 130 is longer than the width D2 of the communication passage 140 in a cross section perpendicular to the axial direction of the inner tube shaft 40 in a state where the outer balloon 80 is expanded by injecting fluid into the second flow path 61. The width D1 of the internal space 130 and the width D2 of the communication path 140 are not particularly limited as long as the width D1 of the internal space 130 is larger than the width D2 of the communication path 140. For example, the width D1 of the internal space 130 is 1.0 mm. The width D2 of the communication path 140 may be 0.1 mm.

  The inner balloon 70 is made of a material harder than the outer balloon 80. The magnitude relationship between the hardness (flexibility) of the constituent material of the inner balloon 70 and the constituent material of the outer balloon 80 can be defined based on the Shore hardness (conforming to JIS 6253).

  The constituent material of the inner balloon 70 and the outer balloon 80 is not particularly limited as long as the constituent material of the inner balloon 70 is harder than the constituent material of the outer balloon 80. For example, the constituent material of the inner balloon 70 may be formed of a material different from the constituent material of the outer balloon 80, or may be formed of the same material as the constituent material of the outer balloon 80. When the inner balloon 70 and the outer balloon 80 are formed of the same material, the inner balloon 70 or the outer balloon 80 is hardened with an additive or the like so that the constituent material of the inner balloon 70 is harder than the constituent material of the outer balloon 80. Adjust.

  As a material constituting the inner balloon 70 and the outer balloon 80, for example, polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these) ), Polymer materials such as polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, etc., or a mixture thereof, or the above two or more kinds of polymer materials.

  The inner balloon 70 can be formed, for example, by processing a parison made of the material constituting the inner balloon 70 into a predetermined balloon shape by biaxial stretch blow molding.

  Similarly, the outer balloon 80 can be formed by processing a parison made of the material constituting the outer balloon 80 into a predetermined balloon shape by, for example, biaxial stretch blow molding. When the outer balloon 80 is formed by the above-described method, the parison of the outer balloon 80 is provided with a portion corresponding to the opening or the convex portion 100 that forms the communication path 140.

  Next, with reference to FIG. 4 and FIG. 5, the method for treating the lesion site N of the biological lumen V using the balloon catheter 1 according to the present embodiment will be described.

  The treatment method using the balloon catheter 1 according to the present embodiment includes a step of inserting the balloon catheter 1 into the living body lumen V, a step of placing the outer balloon 80 at the lesion site N of the living body lumen V, and the outer balloon 80. A step of forming the convex portion 100 on the outer surface 80S side, a step of expanding the inner balloon 70, a step of adsorbing the convex portion 100 to the lesion site N, and the inner balloon 70 via the outer balloon 80 on the lesion site N. Adapting the expansion force.

  In the step of inserting the balloon catheter 1 into the living body lumen V, the operator inserts the guide wire W into the living body lumen V, passes the distal end side of the guide wire W to the lesion site N, and moves along the guide wire W. The balloon catheter 1 is inserted into the living body lumen V.

  Referring to FIGS. 4 and 5A, in the step of placing outer balloon 80 at lesion site N of living body lumen V, the operator places balloon catheter 1 inserted into living body lumen V with lesion site N. The first intermediate region 85 of the outer balloon 80 is placed at the lesion site N of the living body lumen V while confirming the X-ray contrast marker C of the balloon 20.

  5B, in the step of forming the convex portion 100 on the outer surface 80S side of the outer balloon 80, the surgeon places the second flow path 61 in a state where the outer balloon 80 is disposed at the lesion site N. By injecting fluid into the outer balloon 80, the outer balloon 80 is expanded in the circumferential direction. Thereby, the convex part 100 which protruded in the outer surface 80S side of the outer side balloon 80 is formed. The fluid is injected into the second flow path 61 through the second port 36 of the hub 30.

  Referring to FIG. 5C, in the step of expanding inner balloon 70, the surgeon operates the inner balloon so that convex portion 100 of outer balloon 80 comes into contact with lesion site N in a state where outer balloon 80 is expanded. 70 is expanded in the circumferential direction. The expanded state of the outer balloon 80 can be maintained by preventing fluid from flowing in and out of the second flow path 61. When the inner balloon 70 is expanded in the circumferential direction, a fluid is injected into the first flow path 51. The fluid is injected into the first flow path 51 through the first port 35 of the hub 30.

  The surgeon positions the balloon 20 with the X-ray contrast marker C so that the lesion site N is disposed between the first convex portion 101 and the second convex portion 102 of the outer balloon 80. Thereafter, the surgeon expands the inner balloon 70 in a state where the lesion site N is disposed between the first convex portion 101 and the second convex portion 102 of the outer balloon 80.

  Referring to FIGS. 5D and 6, in the step of adsorbing convex portion 100 to lesion site N, the operator is in a state where convex portion 100 is in contact with lesion site N and inner balloon 70 is expanded. The outer balloon 80 is deflated. Then, a negative pressure is generated between the convex portion 100 and the lesion site N. When the outer balloon 80 is deflated, the operator discharges the fluid from the second flow path 61 via the second port 36 of the hub 30.

  In the step of applying the expansion force of the inner balloon 70 to the lesion site N via the outer balloon 80, the operator performs the inner side operation in a state where the inner balloon 70 is expanded and the outer balloon 80 is adsorbed to the lesion site N. The balloon 70 is further expanded in the circumferential direction, and the expansion force of the inner balloon 70 is applied to the lesion site N via the outer balloon 80. The lesion site N is expanded by the expansion force of the inner balloon 70. The state in which the outer balloon 80 is adsorbed to the lesion site N can be maintained by preventing fluid from flowing in and out of the second flow path 61.

  After the treatment with the balloon catheter 1 is completed, the outer balloon 80 is expanded in the circumferential direction by injecting a fluid into the second flow path 61, and is generated between the convex portion 100 and the lesion site N after the treatment. Release negative pressure. Then, the outer balloon 80 is deflated while the inner balloon 70 is deflated or the inner balloon 70 is deflated so that a negative pressure is not generated between the convex portion 100 and the lesion site N after treatment. Then, with the inner balloon 70 and the outer balloon 80 deflated, the balloon catheter 1 is removed from the living body lumen V.

  According to the balloon catheter 1 and the treatment method using the balloon catheter 1 according to the present embodiment, the balloon catheter 1 includes the inner balloon 70 and the outer balloon 80 that covers the inner balloon 70. The outer balloon 80 forms a convex portion 100 that protrudes toward the outer surface 80S of the outer balloon 80 in the expanded state by injecting fluid into the second space. And the convex part 100 is between the outer balloon 80 and the biological lumen wall Vw by the fluid of the 2nd flow path 61 being discharged | emitted in the state which the said convex part 100 contacted the biological lumen wall Vw. Generate negative pressure. Thus, the surgeon expands the inner balloon 70 and applies the convex portion 100 of the outer balloon 80 to the living body lumen wall Vw before applying the expansion force of the inner balloon 70 to the lesion site N via the outer balloon 80. Can be adsorbed. Therefore, when the surgeon adapts the expansion force of the inner balloon 70 to the lesion site N via the outer balloon 80, the surgeon adsorbs the convex portion 100 to the living body lumen wall Vw, so that the positions of the balloon 20 and the lesion site N are adjusted. Reduce changes in relationships. Therefore, according to the treatment method using the balloon catheter 1 and the balloon catheter 1, when the expansion pressure of the balloon 20 is applied to the lesion site N, the positional displacement of the balloon 20 in the axial direction can be prevented.

  Further, according to the balloon catheter 1 according to the present embodiment, the convex portion 100 has the upper region 110 and the bottom region 120, and the thickness T1 of the upper region 110 is thinner than the thickness T2 of the bottom region 120. Thereby, since the difference between the rigidity of the upper region 110 and the rigidity of the bottom region 120 becomes large, the balloon catheter 1 has a bottom portion when the pressure in the lumen 81 (second space) of the outer balloon 80 changes. The upper region 110 can be greatly changed while suppressing deformation of the region 120. Therefore, in the balloon catheter 1, when the outer balloon 80 is expanded and the upper region 110 of the convex portion 100 is in contact with the living body lumen wall Vw, the fluid is discharged from the second flow path 61, thereby the upper region 110. Can be greatly recessed toward the inner cavity 81 (second space) side of the outer balloon 80, and a large negative pressure can be generated between the living body lumen wall Vw and the convex portion 100 in a short time. Therefore, the balloon catheter 1 can more reliably prevent displacement of the balloon 20 in the axial direction when the expansion pressure of the balloon 20 is applied to the lesion site N.

  Further, according to the balloon catheter 1 according to the present embodiment, the length H1 of the upper region 110 is shorter than the length H2 of the bottom region 120 in a cross section perpendicular to the axial direction of the inner tube shaft 40. Thereby, since the length of the bottom region 120 is shorter than the length of the upper region 110 in the balloon catheter 1, when the pressure in the lumen 81 (second space) of the outer balloon 80 changes, the upper region 110 is moved to the bottom portion. It can be greatly deformed by the space on the region 120 side. Therefore, in the balloon catheter 1, when the outer balloon 80 is expanded and the upper region 110 of the convex portion 100 is in contact with the living body lumen wall Vw, the fluid is discharged from the second flow path 61, whereby the bottom region 120. The upper region 110 can be further recessed into the space secured on the side, and negative pressure can be efficiently generated between the living body lumen wall Vw and the convex portion 100. Therefore, the balloon catheter 1 can more reliably prevent displacement of the balloon 20 in the axial direction when the expansion pressure of the balloon 20 is applied to the lesion site N.

  Further, according to the balloon catheter 1 according to the present embodiment, the width D1 of the inner space 130 is in the axial direction of the inner tube shaft 40 in a state where the outer balloon 80 is expanded by injecting fluid into the second flow path 61. The vertical cross section is longer than the width D2 of the communication path 140. Thereby, when the balloon catheter 1 deflates the expanded outer balloon 80, the width D2 of the communication path 140 is shorter than the width D1 of the inner space 130. The force of the fluid flowing to the inner cavity 81 (second space) side is not dispersed in the communication path 140, and the upper region 110 can be recessed more efficiently on the bottom region 120 side. Therefore, the balloon catheter 1 allows the fluid to be discharged from the second flow path 61 in a state where the outer balloon 80 is expanded and the upper region 110 of the convex portion 100 is in contact with the living body lumen wall Vw. It is possible to generate a negative pressure more efficiently between the living body lumen wall Vw and the convex portion 100 by greatly denting the outer balloon 80 toward the inner cavity 81 (second space) side. Therefore, the balloon catheter 1 can more reliably prevent displacement of the balloon 20 in the axial direction when the expansion pressure of the balloon 20 is applied to the lesion site N.

  Further, according to the balloon catheter 1 according to this embodiment, the inner balloon 70 is made of a material harder than the outer balloon 80. As a result, when applying the expansion force by the inner balloon 70 to the lesion site N, the surgeon can more reliably adapt the expansion pressure of the inner balloon 70 to the lesion site N via the outer balloon 80. Therefore, the surgeon can perform the procedure using the balloon catheter 1 more suitably.

  Further, according to the balloon catheter 1 according to the present embodiment, the convex portion 100 is formed in the first intermediate region 85. The first intermediate region 85 is disposed between the first distal-side inclined portion 86 and the first proximal-side inclined portion 87 when the outer balloon 80 is expanded, and has a maximum outer diameter portion that contacts the living body lumen wall Vw. This is a region to be formed. Therefore, the convex part 100 can be reliably brought into contact with the biological lumen wall Vw when the outer balloon 80 is expanded by being arranged in the first intermediate region 85. Therefore, in the balloon catheter 1, the fluid is discharged from the second flow path 61 in a state where the outer balloon 80 is expanded and the upper region 110 of the convex portion 100 is in contact with the living body lumen wall Vw, thereby the living body lumen. A negative pressure can be more reliably generated between the wall Vw and the convex portion 100.

  Further, according to the balloon catheter 1 according to the present embodiment, the first intermediate region 85 includes the first convex portion 101 and the second convex portion 102 at different locations in the axial direction of the outer balloon 80. Thereby, the balloon catheter 1 can firmly fix the balloon 20 to the biological lumen wall Vw by adsorbing the first convex portion 101 and the second convex portion 102 to the biological lumen wall Vw. Further, the second intermediate region 75 is disposed at a position corresponding to between the first convex portion 101 and the second convex portion 102 in a state where the inner balloon 70 and the outer balloon 80 are expanded. Thereby, when the inner balloon 70 is expanded, the balloon catheter 1 is disposed between the second distal end inclined portion 76 and the second proximal end inclined portion 77, and forms the maximum outer diameter portion of the inner balloon 70. The two intermediate regions 75 are disposed between the first convex portion 101 and the second convex portion 102 adsorbed on the living body lumen wall Vw. Therefore, the balloon catheter 1 can reliably apply the expansion pressure of the inner balloon 70 to the lesion site N via the outer balloon 80. Therefore, the balloon catheter 1 can more surely adapt the expansion pressure of the balloon 20 to the lesion site N while further reliably preventing the displacement of the balloon 20 in the axial direction.

  Further, according to the balloon catheter 1 according to the present embodiment, the first convex portion 101 is disposed at the distal end portion 85 a of the first intermediate region 85, and the second convex portion 102 is the proximal end portion of the first intermediate region 85. 85b. Thereby, the balloon catheter 1 contacts the living body lumen wall Vw, and the first convex portion 101 and the first convex portion 101 are formed on the distal end portion 85a and the proximal end portion 85b of the first intermediate region 85 that forms the maximum outer diameter portion of the outer balloon 80. Two convex portions 102 are provided. Therefore, in the balloon catheter 1, the first convex portion 101 and the second convex portion 102 form a living body lumen that forms a lesion site N at both ends 85a and 85b of the first intermediate region 85 that contacts the living body lumen wall Vw. It can be more stably fixed to the wall Vw. Further, when the second intermediate region 75 of the inner balloon 70 is disposed at a position corresponding to between the first convex portion 101 and the second convex portion 102, the balloon catheter 1 has the first convex portion 101 and the second convex portion. Since a long distance from the part 102 can be secured, a wide range in which the expansion pressure by the inner balloon 70 can be surely applied to the lesion site N can be secured. Therefore, the balloon catheter 1 can secure a wide range in which the expansion pressure of the balloon 20 can be reliably applied to the lesion site N when the expansion pressure of the balloon 20 is applied to the lesion site N, and the balloon catheter 1 in the axial direction of the balloon 20 can be secured. Misalignment can be prevented more reliably.

  Further, according to the balloon catheter 1 according to the present embodiment, the upper region 110 of the convex portion 100 has the thickness T1 of the upper region 110 smaller than the thickness T2 of the bottom region 120 and the radial direction of the outer balloon 80. It extends along a plane substantially perpendicular to. Thus, when the upper region 110 forms a curved surface on the radial side of the outer balloon 80 when the expanded outer balloon 80 is deflated (for example, in the first modification described later with reference to FIG. 7). Compared with the configuration), the upper region 110 of the convex portion 100 can be brought into close contact with the biological lumen wall Vw while pressing the radial direction side of the bottom region 120 of the convex portion 100 against the biological lumen wall Vw. The decompression space Sr can be more reliably formed between the cavity wall Vw and the upper region 110. Further, when the outer balloon 80 is deflated, the edge of the portion of the upper region 110 facing the internal space 130 of the upper region 110 is easily deformed when the outer balloon 80 is deflated. Therefore, it can be recessed more smoothly toward the internal space 130. Therefore, the balloon catheter 1 can generate a negative pressure between the outer balloon 80 and the living body lumen wall Vw more reliably and firmly.

(Modification 1)
In the embodiment described above, the upper region 110 of the convex portion 100 extends along a plane substantially orthogonal to the radial direction of the outer balloon 80. However, the shape of the upper region of the convex portion is such that the negative pressure is generated between the outer balloon and the biological lumen wall by discharging the fluid in the second flow path in a state where the convex portion is in contact with the biological lumen wall. As long as it is generated, there is no particular limitation.

  For example, as shown in FIG. 7, in the upper region 210 of the convex portion 200, the radial direction end of the outer balloon 80 may form a curved surface. Also with the balloon catheter according to this modification, when the balloon is expanded in the living body lumen, it is possible to prevent the displacement of the balloon in the axial direction.

(Modification 2)
In the above-described embodiment, the outer balloon 80 includes the communication path 140. However, as shown in FIG. 8, the outer balloon 280 may not include a communication path. Also with the balloon catheter according to this modification, when the balloon is expanded in the living body lumen, it is possible to prevent the displacement of the balloon in the axial direction.

  As described above, the balloon catheter has been described through the embodiment and the modifications thereof. However, the present invention is not limited to the configuration described in the embodiment and the modification, and may be appropriately changed based on the description of the claims. It is possible.

  For example, in the above-described embodiment and its modification, three convex portions are arranged in the circumferential direction of the outer balloon. However, the number of convex portions is not particularly limited, and may be one, two, or four or more in the circumferential direction of the outer balloon.

  Moreover, the convex part had the 1st convex part and the 2nd convex part which were arrange | positioned in the location which differs in the axial direction of an outer side balloon in a 1st intermediate | middle area | region. However, one or more convex portions may be arranged along the axial direction of the outer balloon in the first intermediate region.

  Furthermore, the convex part was arrange | positioned in the 1st intermediate | middle area | region. However, the convex part may be arrange | positioned at the 1st inclination area | region part and / or the 2nd inclination part.

1 balloon catheter,
40 Inner tube shaft,
40S The outer peripheral surface of the inner tube shaft,
50 first outer tube shaft,
50S outer peripheral surface of the first outer tube shaft,
51 1st flow path (1st space),
60 second outer tube shaft,
61 2nd flow path (2nd space),
70 inner balloon,
71 first lumen (first space),
75 second intermediate region,
76 second tip side inclined portion,
77 second base side inclined portion,
80, 280 outer balloon,
The outer surface of the 80S outer balloon,
81 second lumen (second space),
85 first intermediate region;
86 first tip side inclined portion,
87 1st base end side inclined part,
100, 200 convex part,
101 first convex part,
102 second convex part,
110, 210 Upper region of the convex part,
120, the bottom area of the convex part,
130 interior space,
140 communication path,
D1 width of internal space,
D2 The width of the communication path,
N lesion site,
S biological lumen wall,
The thickness of the upper region of T1,
T2 Thickness of bottom area,
V Biological lumen.

Claims (9)

An inner tube shaft through which a guide wire can be inserted;
A first outer tube shaft that is disposed on the outer peripheral surface side of the inner tube shaft and that forms a first space in which a fluid can move between the inner tube shaft;
A second outer tube shaft disposed on the outer peripheral surface side of the first outer tube shaft and forming a second space in which fluid can move between the first outer tube shaft;
An inner balloon fixed to the distal end side of the inner tube shaft and the distal end side of the first outer tube shaft;
An outer balloon fixed to the distal end side of the inner tube shaft and the distal end side of the second outer tube shaft, and covering the inner balloon;
The outer balloon is in a state of being expanded by injecting fluid into the second space, and forms a convex portion that protrudes to the outer surface side of the outer balloon,
The convex portion generates a negative pressure between the outer balloon and the biological lumen wall by discharging the fluid in the second space in a state where the convex portion is in contact with the biological lumen wall. , Balloon catheter. The convex portion has an upper region and a bottom region formed on the inner balloon side than the upper region,
The upper region is thinner than the bottom region,
The convex portion discharges the fluid in the second space in a state where the outer balloon is expanded by injecting fluid into the second space and the convex portion is in contact with the living body lumen wall. The balloon catheter according to claim 1, wherein a decompression space is formed between the upper region and the living body lumen wall.   The balloon catheter according to claim 2, wherein a length of the upper region is shorter than a length of the bottom region in a cross section perpendicular to the axial direction of the inner tube shaft. The convex portion has an internal space into which the fluid of the second space flows in a state where the outer balloon is expanded,
The outer balloon has a communication path between the inner space and the second space,
The width of the internal space is longer than the width of the communication path in a cross section perpendicular to the axial direction of the inner tube shaft in a state where the outer balloon is expanded. Balloon catheter.   The balloon catheter according to any one of claims 1 to 4, wherein the inner balloon is made of a material harder than the outer balloon. The outer balloon includes a first intermediate region having a distal end and a proximal end, a first distal-side inclined portion inclined from the distal end of the first intermediate region toward the inner tube shaft, and a proximal end of the first intermediate region And a first base end side inclined portion that is inclined toward the second outer tube shaft,
The balloon catheter according to any one of claims 1 to 5, wherein the convex portion is formed in the first intermediate region. The inner balloon includes a second intermediate region having a distal end and a proximal end, a second distal-side inclined portion inclined from the distal end of the second intermediate region toward the inner tube shaft, and a proximal end of the second intermediate region And a second base-side inclined portion that is inclined toward the second outer tube shaft,
The convex portion has a first convex portion and a second convex portion arranged at different locations in the axial direction of the outer balloon in the first intermediate region,
The balloon according to claim 6, wherein the second intermediate region is disposed at a position corresponding to between the first convex portion and the second convex portion in a state where the inner balloon and the outer balloon are expanded. catheter. The first convex portion is disposed at a tip portion of the first intermediate region,
The balloon catheter according to claim 7, wherein the second convex portion is disposed at a proximal end portion of the first intermediate region. An inner tube shaft through which a guide wire can be inserted, and a first outer tube shaft which is disposed on the outer peripheral surface side of the inner tube shaft and forms a first space in which fluid can move between the inner tube shaft and the inner tube shaft A second outer tube shaft disposed on the outer peripheral surface side of the first outer tube shaft and forming a second space in which fluid can move between the first outer tube shaft and the inner tube shaft. An inner balloon fixed to the distal end side and the distal end side of the first outer tube shaft, and an outer balloon fixed to the distal end side of the inner tube shaft and the distal end side of the second outer tube shaft and covering the inner balloon And inserting a balloon catheter having a body lumen
Placing the outer balloon at a lesion site in the body lumen;
In the state where the outer balloon is arranged at the lesion site, by injecting fluid into the second space, the outer balloon is expanded in the circumferential direction, and a convex portion is formed on the outer surface of the outer balloon,
With the outer balloon expanded, the inner balloon is expanded in the circumferential direction so that the convex portion of the outer balloon is in contact with the lesion site,
In the state where the convex portion is in contact with the lesion site and the inner balloon is expanded, the outer balloon is deflated, thereby generating a negative pressure between the convex portion and the lesion site. A balloon is adsorbed to the lesion,
In a state where the inner balloon is expanded and the outer balloon is adsorbed to the lesion site, the inner balloon is further expanded in the circumferential direction, so that the lesion balloon is inserted into the lesion site via the outer balloon. A method for treating the lesion site of the biological lumen, adapting expansion force.